Winter respiratory viral infections in care home residents Respiratory
Conditions
Interventions
Homes, and not participants, will be randomised. Randomisation will be stratified by care home type (residential vs nursing/mixed), prior COVID-19 in phase 1 of pandemic (yes vs no), and size of care
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Residents from 26 participating care homes (residential and nursing) with 16 participants from each 2. Aged =65 years 3. Currently consuming a normal diet 4. Willing to take treatment having taste-tested a beetroot shot
Exclusion criteria
Exclusion criteria: 1. Unwilling to participate or opted-out of the trial (resident, or family, if resident lacks capacity) 2. Currently consuming a soft diet or using a thickener 3. Using antiseptic mouthwash 4. Identified by care home staff to be in the last few days of life 5. Short-term respite care 6. Care home staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Feasibility of conducting a larger scale trial assessed using data on the recruitment of care homes, recruitment of residents, assessment of background infection rate, assessment of background dietary nitrate intake, adherence to the intervention, ability to measure the ordinal outcome, an estimation of the intra-cluster correlation (ICC), and incidence of death between baseline and 60 days 2. Severity of the first infection measured using a 5 level ordinal outcome (using the worst level if >1 event, where a score of: 0 represents no symptoms of infection; 1 represents symptoms of infection; 2 represents symptoms of infection needing healthcare advice such as a call to 111, or GP appointment; 3 represents hospitalisation for any reason, or intention to hospitalise but advance directive precluded this; or 4 represents death from any cause) between baseline and 60 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Severity of worst infection stratified by subgroups of age (median), sex, size of home (median), type of care home (residential, nursing), home’s location (median deprivation index), and infection location (respiratory tract, gastrointestinal tract, urinary tract, cutaneous) measured using a 5 level ordinal outcome (where a score of: 0 represents no symptoms of infection; 1 represents symptoms of infection; 2 represents symptoms of infection needing healthcare advice such as a call to 111, or GP appointment; 3 represents hospitalisation for any reason, or intention to hospitalise but advance directive precluded this; or 4 represents death from any cause) between baseline and 60 days 2. Number of infections measured using patient records between baseline and 60 days 3. Time to first infection measured using patient records between baseline and first identification of infection 4. Time to first hospitalisation or death in home measured using patient records between baseline and first record of hospitalisation or death in home 5. Disposition at day 60 measured using patient records (options such as care home, with relative/friend, another home, hospital, or died) at 60 days 6. Frailty measured using the Clinical Frailty Index (CFI) at baseline and 60 days 7. Activities of daily living measured using the Barthel index (BI) at baseline and 60 days 8. Cognitive impairment measured using the 6 item cognitive impairment test (6CIT) at baseline and 60 days 9. Quality of life measured using the visual analogue scale (EQ-VAS) and the EuroQol 5-dimension 5-level (EQ-5D-5L) quality of life questionnaire at baseline and 60 days 10. Global outcome measured as a combination of the severity of first infection, frailty, activities of daily living, cognitive impairment, and quality of life at baseline and 60 days 11. Incide | — |
Countries
England, United Kingdom
Contacts
Public ContactDiane Havard
Outcome results
None listed